Short Form Consents and the Unexpected Non-English Speaking Participant

For research sites whose communities include large populations of non-English speakers, it may be standard operating procedure (SOP) to obtain a translated version(s) of the study’s informed consent document at the beginning of each study. That way, when a non-English speaking potential study participant shows interest in the trial, researchers can help the potential participant learn more about the research without missing a beat.

But what about situations where a non-English speaking potential participant shows up unexpectedly, and there isn’t enough time to obtain a translated study consent?

Enter the short form consent.

Regulatory Perspective on Short Form Consents

The regulations require presenting study information in a language understandable to research participants—this includes, of course, the informed consent document and process.

45 CFR 46.117(b)(2) and 21 CFR 50.27 allow researchers to provide non-English speaking potential participants with an oral presentation of the informed consent information in conjunction with a written short form consent document and a written summary of the oral presentation.

A witness must be at hand for the oral presentation, and the participant must receive copies of the short form and summary documents. The long form English consent may serve as the written summary.

FDA and Office of Human Research Protections (OHRP) guidance documents suggest the agencies clearly prefer a non-English speaking participant review a translated version of the complete study consent. But we know this may not always be possible.

How do You Use a Short Form Consent?

For those unexpected situations, some institutions and institutional review boards (IRBs) maintain an approved short form consent translated into multiple languages. This way, researchers don’t have to turn away a potential study participant just because the study consent is not available in the non-English speaker’s language.

Keep in mind: The short form consent isn’t the perfect solution—an interpreter must also be present to assist with the oral consent presentation. Documentation requirements still must be followed as well. This includes:

• The short form consent should be signed by the study participant or the participant’s (LAR)
• The written summary should be signed by the person obtaining consent
• The witness (who may also be the interpreter) should sign both the short form and the summary
  • While not required, OHRP guidance and best practice suggest the witness should be fluent in English as well as the participant’s language

The short form consent can be a useful tool for unexpected situations, but it should not be used when investigators already anticipate non-English speakers will enroll in the research. If you expect non-English speaking participants, be proactive and have the study consent translated into the language(s) commonly used in your community.

Remember, informed consent is an ongoing process. While the short form consent can help during the initial consent discussion, researchers still need to assemble the proper communication tools to ensure the non-English speaking participant understands matters things throughout the study.

Non-English speaking study participants require additional support throughout the course of a study, but with the right tools and a little regulatory know-how, researchers can help ensure these participants are able to provide meaningful research contributions and reap potential benefits.

Note: This article was originally published August 30, 2017, and has been updated to include new and clarifying information.

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